OBJECTIVE: Evaluate the safety and efficacy of intravenous golimumab in psoriatic arthritis (PsA). METHODS: In this Phase 3, randomized, double-blind, placebo-controlled trial, patients were randomized to intravenous placebo (n=239) or golimumab 2 mg/kg (n=241) at weeks 0, 4, 12, and 20. The primary endpoint was the proportion of patients with ≥20% improvement in ACR criteria (ACR20) at week14. Controlled secondary endpoints included change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI), proportions of patients with ACR50, ACR70, and ≥75% improvement in Psoriasis Area and Severity Index (PASI75) at week14, and change from baseline in total PsA-modified van der Heijde-Sharp (vdH-S) score at week24...

BACKGROUND AND PURPOSE: Trials of restorative therapies after stroke and clinical rehabilitation require relevant and objective efficacy end points; real-world upper extremity (UE) functional use is an attractive candidate. We present a novel, inexpensive, and feasible method for separating UE functional use from nonfunctional movement after stroke using a single wrist-worn accelerometer. METHODS: Ten controls and 10 individuals with stroke performed a series of minimally structured activities while simultaneously being videotaped and wearing a sensor on each wrist that captured the linear acceleration and angular velocity of their UEs...

OBJECTIVES AND DESIGN: Despite an increasing awareness of the importance of fidelity of delivery within complex behaviour change interventions, it is often poorly assessed. This mixed methods study aimed to establish the fidelity of delivery of a complex self-management intervention and explore the reasons for these findings using a convergent/triangulation design. SETTING: Feasibility trial of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention (ISRCTN49875385), delivered in primary care physiotherapy...

BACKGROUND: The relative safety of long-term utilization of non-steroidal anti-inflammatory drugs (NSAIDs) is unclear. Patients and providers are interested in an integrated view of risk . We examined the risk of major NSAID toxicity in the PRECISION trial. METHODS: We conducted a post-hoc analyses of double-blind randomized controlled multi-center trial enrolling 24,081 patients with osteoarthritis or rheumatoid arthritis at moderate or high cardiovascular risk...

OBJECTIVE: To examine the prescribing practices of quetiapine for insomnia at a tertiary care child and adolescent psychiatric inpatient unit. METHOD: A retrospective chart review was conducted on all admissions in 2013 involving night-time only prescription of quetiapine. We examined patient demographics, discharge diagnoses, physician's written indications for prescriptions, and maximum doses used. If used for insomnia only, we noted any documentation of past sedative trials, concurrent prescriptions of other sedative agents, whether quetiapine was started in hospital or continued as a part of a community regimen, and whether quetiapine was continued on discharge...

BACKGROUND: Cancer is associated with a prothrombotic state and increases risk of thrombotic events in patients with atrial fibrillation. We described clinical characteristics and outcomes and assessed safety and efficacy of apixaban versus warfarin in patients with atrial fibrillation and cancer in ARISTOTLE. METHODS AND RESULTS: The association between cancer and clinical outcomes was assessed using Cox regression models. At baseline, 1236 (6.8%) patients had a history of cancer; 12...

Although sarcopenic obesity (SO) poses a major public health concern, a robust approach for the optimization of body composition and strength/function in SO has not yet been established. The purpose of this systematic review was to assess the effectiveness of nutritional (focusing on energy and protein modulation) and exercise interventions, either individually or combined, on body composition and strength/function in older adults with SO. MEDLINE, the Cochrane Central Register of Controlled Trials, CINAHL and SPORTDiscus were searched...

Importance: The population of infants, children, and adolescents cared for at pediatric long-term care facilities is increasing in complexity and size and thus consumes substantial health care resources. Infections are a significant cause of morbidity and mortality in this population, but few recent data describe their incidence and effects. Objectives: To describe the types of infections diagnosed in residents of pediatric long-term care facilities, calculate infection rates, and identify risk factors for respiratory tract infections (RTIs)...

Squamous cell carcinoma of the lung arises from preinvasive progenitors in the central airways. The archetypal model appears to be a stepwise morphological progression until there is invasion of the basement membrane. However, not every lesion appears to follow this course and many individuals can have stable disease, or indeed regress to normal epithelium. From our increased understanding of the molecular pathology it is becoming apparent that the respiratory epithelium accumulates progressive genetic and epigenetic insults in response to carcinogens...

Although previous research has confirmed that nurse staffing affects patient outcomes, some potentially important factors have not been accounted for in tools to assess relationships between staffing and outcomes. The aim of this project was to develop and test a Nursing Intensity of Care Index using electronically available data from 152 072 patient discharges from three hospitals. Initially, 1765 procedure codes were reviewed; 69 were confirmed as directly increasing nursing workload by at least 15 minutes per shift...

INTRODUCTION: Social support is important for behavior change, and it may be particularly important for the complexities of changing multiple risk behaviors (MRB). Research is needed to determine if participants in an MRB intervention can be encouraged to activate their social network to aid their change efforts. METHODS: Healthy Directions 2, a cluster-randomized controlled trial of an intervention conducted in two urban health centers, targeted five behaviors (physical activity, fruit and vegetable intake, red meat consumption, multivitamin use, and smoking)...

OBJECTIVE: The aim of this study was to determine the influence of perceived authority on pediatric resuscitation teams' response to an incorrect order given by a medical superior. METHODS: As part of a larger multicenter prospective interventional study, interprofessional pediatric resuscitation teams (n = 48) participated in a video-recorded simulated resuscitation scenario with an infant in unstable, refractory supraventricular tachycardia. A confederate actor playing a senior physician entered the scenario partway through and ordered the incorrect dose and delivery method of the antiarrhythmic, procainamide...

OBJECTIVES: To describe the criteria that currently guide empiric antibiotic treatment in children admitted to Canadian PICUs. DESIGN: Cross-sectional survey. SETTING: Canadian PICUs. SUBJECTS: Pediatric intensivists and pediatric infectious diseases specialists. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We used focus groups and literature review to design the survey questions and its four clinical scenarios (sepsis, pneumonia, meningitis, and intra-abdominal infections)...

BACKGROUND: Cardiac biomarkers are independent risk markers in atrial fibrillation, and the novel biomarker-based ABC stroke score (age, biomarkers, and clinical history of prior stroke) was recently shown to improve the prediction of stroke risk in patients with atrial fibrillation. Our aim was to investigate the short-term variability of the cardiac biomarkers and evaluate whether the ABC stroke risk score provides a stable short-term risk estimate. METHODS AND RESULTS: According to the study protocol, samples were obtained at entry and also at 2 months in 4796 patients with atrial fibrillation followed for a median of 1...

OBJECTIVE: To use Linear Programming (LP) analyses to adapt New Complementary Feeding Guidelines (NCFg) designed for infants aged 6-12 month (m) living in poor socioeconomic circumstances in Bogota to ensure dietary adequacy for young children aged 12-23 m. DESIGN: A secondary data analysis was performed using dietary and anthropometric data collected from 12 m old infants (n = 72) participating in a randomised controlled trial. LP analyses were performed to identify nutrients whose requirements were difficult to achieve using local foods as consumed; and to test and compare the NCFg and alternative food-based recommendations (FBRs) on the basis of dietary adequacy, for 11 micronutrients, at the population level...

Children in pediatric long-term care facilities (pLTCF) represent a highly vulnerable population and infectious outbreaks occur frequently, resulting in significant morbidity, mortality, and resource use. The purpose of this quasi-experimental trial using time series analysis was to assess the impact of a 4-year theoretically based behavioral intervention on infection prevention practices and clinical outcomes in three pLTCF (288 beds) in New York metropolitan area including 720 residents, ages 1 day to 26 years with mean lengths of stay: 7...

BACKGROUND: Duchenne muscular dystrophy (DMD) is a rare disease that causes the progressive loss of motor abilities such as walking. Standard treatment includes physiotherapy. No trial has evaluated whether or not adding aquatic therapy (AT) to land-based therapy (LBT) exercises helps to keep muscles strong and children independent. OBJECTIVES: To assess the feasibility of recruiting boys with DMD to a randomised trial evaluating AT (primary objective) and to collect data from them; to assess how, and how well, the intervention and trial procedures work...